Project Manager, Quality Assurance/ Regulatory Affairs

JOB OVERVIEW:

The position is responsible for managing critical projects for Henry Schein Products Group (HSPG) businesses with a Quality Assurance and Regulatory Affairs (QA/RA) focus. This role works with QA/RA team members as well as other functions to put together key actions items, key dependencies, and timelines to ensure projects are successful.

KEY RESPONSIBILITIES: 

• Lead the planning, execution, and successful delivery of strategic Quality and Regulatory Affairs initiatives, including electronic Quality Management System (eQMS) implementations, QMS remediation programs, quality system integrations, process harmonization projects, and compliance-driven business transformations. (40%)
• Develop and maintain integrated project plans, resource forecasts, budgets, timelines, risk registers, and governance frameworks to ensure projects are delivered on schedule, within scope, and in compliance with applicable requirements. (25%)
• Assess, manage, and escalate project risks, regulatory impacts, resource constraints, and quality-related issues using risk-based decision-making and structured problem-solving methodologies. (15%)
• Establish and monitor project Key Process Indicators (KPIs), dashboards, and executive reporting metrics; communicate project health, key risks, resource needs, and recommendations to senior leadership. (10%)
• Lead Quality and Regulatory integration activities associated with mergers, acquisitions, divestitures, site transfers, and organizational transformations, including gap assessments, remediation planning, and compliance integration efforts. (10%)

Other Duties may include:

• Facilitate project governance meetings, steering committee reviews, and executive updates.
• Promote best practices in project management, quality systems, and regulatory compliance.
• Participate in facility and Quality Management System Regulations (QMSR) inspections by the Food and Drug Administration (FDA), Notified Body and internal Good Manufacturing Practice (GMP) audits.
• Participates in special projects and performs other duties as required.

SPECIFIC KNOWLEDGE & SKILLS: 

• Proficiency in the Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams). Working knowledge of additional applications such as Visio, Access, Power Bl and SharePoint a plus.
• Experience using quality system electronic applications is a plus.
• Knowledge of EU MDR.
• PMP certification desired
• Demonstrated ability to lead and manage employees while driving effective and efficient processes.
• Demonstrated record of successfully leading quality improvement projects
• Ability to effectively solve problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence.
• Ability to prioritize, multi-task and adapt to change.
• Ability to work effectively in a team environment and build strong working relationships.
• High degree of initiative and self-motivation with a strong sense of accountability
• Experience leading audits and interactions with 3rd party regulatory agencies, including Notified Bodies, United States Food & Drug Administration (FDA), etc.
• Typically, 5 or more years of increasing responsibility and complexity in terms of any applicable professional experience; 1 or more years of project management experience desired.
• Medical devices experience a must. Thorough knowledge of quality system regulations, i.e., QMSR, ISO 13485, Medical Device Single Audit Program (MDSAP), European Union (EU) Medical Device Regulation (MDR), etc.
• undefined 

GENERAL SKILLS & COMPETENCIES: 

•  Strong understanding of industry practices High proficiency with tools, systems, and procedures Good planning/organizational skills and techniques Good decision making, analysis and problem solving skills with ability to multi-task Strong verbal and written communication skills Good presentation and public speaking skills Good interpersonal skills Good conflict resolution skills and ability to deliver difficult messages Ability to build partnerships at all levels within the company, begin to build partnerships externallyResolve complex issues in effective ways 

MINIMUM WORK EXPERIENCE: 

•  Typically 5 to 7 or more years of increasing responsibility in terms of any applicable professional experience. 

PREFERRED EDUCATION: 

• Typically a Bachelor's Degree or global equivalent in related discipline. Master's degree or global equivalent a plus. May hold one or more industry certifications; professional certification may be required to advance. 

TRAVEL / PHYSICAL DEMANDS:

•  Travel typically less than 10%. Office environment. No special physical demands required. 

KNOWLEDGE: 

•  Senior level professional; knowledge and full understanding of one or more disciplines and good knowledge of organization, processes and customers. Good judgment, strong analytical ability, evaluation, originality and ingenuity required to perform tasks. Know and apply the fundamental concepts, practices, and procedures of a particular field. Resolve issues and assignments in creative ways. Some assignments may be broad in nature. May serve as a resource to others to resolve complex problems and issues. May take on project co-lead role as required.  

COMPLEXITY: 

•  Work on problems of diverse scope and moderate impact where analysis of data requires a review of a variety of factors. Use best practices and knowledge of business strategy to solve complex problems; recommend solutions to business challenges. Demonstrate good judgment in selecting methods and techniques for obtaining solutions. Network with senior internal and external personnel in own area of expertise. 

SUPERVISION: 

• Receive minimal instruction on day-to-day work and general instruction on new projects or assignments.  May act as a resource to provide informal guidance for TSMs with less experience. Assignments can be broad in nature. 

PERFORMANCE REQUIREMENTS: 

•  Typically, to advance to a new job level, TSMs must demonstrate professional behavior and should consistently be at the high-end of meets expectations or consistently exceed expectations.

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers

Benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, Generous Time Off, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.

*Benefits may vary by location or status.

Vaccine Requirement

Candidates for this requisition are required to be fully vaccinated against COVID-19 (i.e., 2 weeks after completing their initial COVID-19 vaccination series) pursuant to state/local law.  These standards and/or requirements may vary from those established by the Company. In some jurisdictions there may be an exception for those seeking a medical or religious accommodation. If you require an accommodation, please inform the recruiter or hiring manager.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status. 

For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers

Fraud Alert

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